Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1422078

FEI Number

1000036860

Entity Name

DOUGLAS MEDICAL PRODUCTS, INC

City/State/Country

Mundelein, IL, US

Establishment Address

361 Banbury Rd, Mundelein, IL 60060, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Douglas Medical Products, Inc. (Owner Number: 9011133)

Owner / Operator Contact Address

361 Banbury Rd, --, Mundelein, IL 60060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K932638

PMA Number

N/A

All Registered Proprietary Names

Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products TUBETECH IV Administration Set Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products Douglas Medical Products

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2015-08-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2015-08-28
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-08-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2015-08-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-08-28

Official Correspondent

Douglas Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Douglas Medical Products, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

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3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB
3008412416	Pall International, Sarl	Fribourg, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422078. Last updated year: 2026. Please use registration number 1422078 when referencing this establishment in official correspondence.